Natco partner clears one patent hurdle for US generic launch

This is for the generic version of a popular drug for multiple sclerosis, Copaxone 40 mg

A district court in America has cleared a legal hurdle over the possible launch by Mylan of the generic version of a popular drug for multiple sclerosis (MS), Copaxone 40 mg.

The court declared four other patent claims to be invalid. One more patent claim is pending before a tribunal there.

Mylan, a US drug generics major, is marketing partner of Hyderabad-based Natco Pharma for this particular generic. They would jointly benefit from its possible launch, conditional upon approval from the US Food and Drug Administration (FDA). Natco announced the development on Tuesday.

Natco shares rose six per cent intra day to Rs 700 before ending the day at Rs 690, up 4.5 per cent over the previous close of Rs 660.25 on the BSE exchange.

Copaxone 40 mg/ml had US sales of $3.3 billion for the 12 months ending November 2016. Natco is yet to get FDA approval for its Abbreviated New Drug Application (ANDA) for Copaxone 20 mg, filed five years earlier; patents on it expired in May, 2015. The ANDA for Copaxone 40 mg was filed by Mylan about 18 months earlier.

Beside this brand in question, a couple of generic versions of the drug, including of Sandoz, are already available in the US market.